CDSCO License for Continuous Glucose Monitor Secondary Display

Introduction to Continuous Glucose Monitor Secondary Display and Its Regulatory Importance

The Continuous Glucose Monitor (CGM) Secondary Display is an innovative software medical device designed to relay real-time glucose sensor data to a secondary user, often known as the "follower." This functionality enhances patient care by allowing caregivers or family members to monitor glucose levels remotely, improving timely interventions. Given its role in managing chronic conditions like diabetes, regulatory compliance is critical to ensure safety, reliability, and effectiveness.

In India, the Central Drugs Standard Control Organization (CDSCO) oversees the regulation of such devices, requiring manufacturers and importers to obtain appropriate licenses before marketing. For a Class B device like the CGM Secondary Display software, obtaining the MD5 manufacturing license or the MD15 import license is mandatory. Navigating this regulatory landscape efficiently demands expert knowledge of timelines, documentation, and procedural nuances.

CDSCO Regulatory Framework for Continuous Glucose Monitor Secondary Display

The CDSCO classifies medical devices based on risk, with software devices typically falling under Class A or B if they present low to moderate risk. The CGM Secondary Display, notified under 29/Misc./03/2020-DC (198) on 13.9.2021, is classified as Class B. This classification mandates adherence to specific regulatory requirements, including quality management system compliance and product testing.

Under the Medical Device Rules (MDR) 2017, Class B devices require a manufacturing license (MD5) issued by the State Licensing Authority. For importers, an import license (MD15) granted by the Central Licensing Authority is necessary. Both licenses ensure that the device meets safety and performance standards, supported by documentation such as the Device Master File (DMF) and Plant Master File (PMF).

Risk Classification and License Requirements for Class B Software Devices

Our extensive experience with over 500 companies has shown that understanding risk classification upfront is crucial. Class B devices like the CGM Secondary Display generally involve moderate risk to patients and users, primarily due to their software component's role in real-time data transmission.

The licensing requirements for Class B devices include:

• MD5 Manufacturing License (Form MD3): For manufacturers operating in India.
• MD15 Import License (Form MD14): For importers bringing the device into India.

The MD5 license process is managed by the State Licensing Authority, while MD15 falls under the Central Licensing Authority.

Manufacturing License Process for Continuous Glucose Monitor Secondary Display (MD5 License)

Obtaining the MD5 license involves several well-defined steps:

1. Test License Application (Form MD13): Initially, manufacturers apply for a test license, which takes approximately 1.5 to 2 months to obtain. This allows for product testing.
2. Product Testing: The device must be tested at government-approved laboratories to verify compliance with relevant standards. Refer to the Testing Laboratories list for authorized labs.
3. Document Preparation: Simultaneously, prepare essential documentation including the Device Master File and Plant Master File.
4. Application Submission (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit is conducted by a notified body listed on the Notified Bodies List, focusing on quality management systems and manufacturing facilities.
6. Query Resolution: Address any queries raised by the CDSCO or the notified body promptly.
7. License Grant: Upon satisfactory completion, the MD5 license is issued on Form MD5.

The entire process typically spans 3 to 4 months.

Manufacturing License Documents Required for CGM Secondary Display

For Class B devices like the CGM Secondary Display, thorough documentation is key. The primary documents include:

• Company Constitution: Proof of legal entity.
• Proof of Ownership or Agreement for Premises: Manufacturing site details.
• Technical Staff Qualification Documents: Details of qualified personnel.
• Fire NOC and Pollution Control NOC: Safety and environmental compliances.
• Device Master File (DMF): Comprehensive technical details of the device. Our detailed Device Master File guide can assist in preparation.
• Plant Master File (PMF): Documentation of manufacturing processes. Learn more from our Plant Master File guide.
• Essential Principles Checklist: Compliance with safety and performance requirements.
• Risk Management File: Risk assessment and mitigation strategies tailored for the device. Refer to our Risk Management resource for best practices.
• Test Reports: From government-approved labs.
• Labels and Instructions for Use (IFU): Device labeling and user guidance.
• Quality Management System (QMS) Documents: ISO 13485 certifications and internal processes.

Import License Process for Continuous Glucose Monitor Secondary Display (MD15 License)

If importing the CGM Secondary Display into India, the MD15 license is mandatory. The process includes:

1. Document Preparation: Compile all required documents ahead of application.
2. Application Submission (Form MD14): Submit through the CDSCO MD Online Portal.
3. Query Resolution: Promptly address any departmental queries.
4. License Grant: Upon satisfaction, the MD15 license is issued.

This process can take approximately 5 to 6 months as it involves a more centralized and stringent review.

Import License Documents Required

Key documents for MD15 application include:

• Manufacturing License of the device in the country of origin.
• Free Sale Certificate from the exporting country.
• ISO 13485:2016 Certificate.
• CE Certificate or other international compliance certificates.
• Device Master File and Plant Master File.
• Wholesale license, if applicable.
• Company Constitution and address proof.

Timeline and Processing Duration

Starting early with document preparation and lab testing can significantly reduce delays.

Government Fees and Costs

For the CGM Secondary Display, classified as Class B, the government fees are:

• MD5 License: Rs 5,000 per application + Rs 500 per product.
• MD15 Import License: $2,000 per site +$1,000 per product.

These fees exclude costs of product testing, notified body audits, and internal preparation, which should be budgeted accordingly.

Common Challenges and Solutions

• Delayed Test Reports: Testing at government-approved labs can be time-consuming. We recommend scheduling tests well in advance and considering labs with faster turnaround times.
• Incomplete Documentation: Missing or inconsistent documentation is a frequent cause of rejection. Use checklists and professional templates.
• Audit Non-compliance: Non-adherence to QMS or manufacturing standards can lead to audit failures. Pre-audit internal reviews and mock audits help mitigate this risk.
• Query Delays: Slow responses to CDSCO queries can prolong timelines. Assign dedicated team members for prompt communication.

Expert Consultation and Support

With over 25 years of experience and 500+ successful CDSCO license applications, we provide end-to-end support—from initial classification to final license grant. Our expertise includes:

• In-depth documentation preparation
• Coordination with notified bodies and testing labs
• Strategic timeline management
• Regulatory updates and compliance training

Contact us early in your project to streamline your path to market.

Getting Started with Your CDSCO License Application

1. Evaluate Device Classification: Confirm Class B status via the Medical Device Classification guide.
2. Prepare Documentation: Assemble company, technical, and device-related files using expert templates.
3. Apply for Test License (MD13): Submit through the CDSCO MD Online Portal.
4. Schedule Product Testing: Engage approved laboratories and monitor timelines.
5. Plan for Audit: Choose a notified body from the official Notified Bodies List.
6. Submit Manufacturing License Application (MD3): Ensure all documents and test reports are in order.
7. Monitor and Respond: Track application status and resolve queries promptly.

By following these actionable steps and leveraging our expert support, manufacturers and importers can confidently navigate the CDSCO licensing process for the Continuous Glucose Monitor Secondary Display, ensuring timely and compliant market entry in India.